Pharmaceuticals - Community Register

  

Community register of orphan medicinal products


GRANTED  

Product information

Obeticholic acid

EU orphan designation number: EU/3/13/1228   
Active ingredient: Obeticholic acid
Indication: Treatment of primary sclerosing cholangitis
Sponsor: Intercept Italia S.R.L.
c/o Studio Enrico Pellegrini, Via Settevalli 556, 06129 Perugia, Italia

   Public summary of scientific opinion    

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
21/01/2014 Centralised Orphan - Designation EMA/OD/136/13 (2014)298 of 16/01/2014